Psoriasis is an autoimmune disease that causes red, scaly
patches on the skin and affects as many as 7.5 million in the
U.S., according to the National Psoriasis Foundation. The market
for treatments may approach $10 billion worldwide, according to
Mark Schoenebaum, an analyst with ISI Group Inc. in New York. He
said investors may have been looking for at least 40 percent of
patients reaching the PASI-75 metric.

“This would place apremilast slightly less effective than
the biologic therapies (e.g., Enbrel, Humira, Stelara) but with
a best-in-class safety profile,” Schoenebaum wrote in a Feb. 28
research note.

The data presented today were from a study called ESTEEM 1,
one of two clinical trials in the third and final phase
generally required for regulatory approval. Summit, New Jersey-
based Celgene said in January that both ESTEEM 1 and ESTEEM 2,
which together included about 1,250 patients, had met their
study goals and that it plans to seek regulatory approval for
apremilast in psoriasis in the second half of this year.

Psoriatic Arthritis

Celgene also has tested the drug in psoriatic arthritis,
another autoimmune condition, and has plans to apply for
approval in that indication in the first half of this year. It’s
also running trials in ankylosing spondylitis, Behcet’s disease
and rheumatoid arthritis. Apremilast may bring in $1.14 billion
in revenue in 2017, according to the average of 12 analysts’
estimates compiled by Bloomberg.

Celgene today also reported that 59 percent of patients
achieved a 50 percent reduction in symptoms, compared with 17
percent of those taking a placebo. The drug was generally well
tolerated, with a 3.6 percent of patients on apremilast and 3.2
percent on placebo reporting severe side effects, Celgene said.